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Biostatistical Service for Medical Devices

Biostatistical Service for Medical Devices

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Author: murphy wu
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Biostatistical Service for Medical Devices

Medical devices is “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, accessory, which is 1) recognized in the Official National Formulary, or the United States Pharmacopoeia, or any supplement to them, 2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or 3) intended to affect the structure, or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animal and which is not dependent upon being metabolized for the achievement of its primary intended purposes” – [U.S. Code, FD & C Act; 21 US Code 321 (h)].

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